FDA says PREDICT border control programme is delayed

The US Food and Drug Administration's PREDICT programme, a risk-management approach to help customs officers prevent adulterated and counterfeit food and drug products entering the country, has been delayed by IT problems.

The border initiative is designed to allow border inspectors to monitor products at the port of entry and to focus inspections on shipments that pose the greatest risk.

At the moment, inspectors can only monitor a fraction of the 20 million or more shipments that reach the USA's shores each year, and have to rely on random sampling. PREDICT is an attempt to set up a screening approach that will allow higher-risk shipments to be scrutinised based on their contents, supplier and source.

It started to roll out earlier this year with a pilot in Los Angeles and an initial implementation in New York, and was scheduled to be rolled out nationally by the end of Spring 2010, but has now been delayed "indefinitely," according to a report on Drug Industry Daily.

PREDICT makes use of barcode scanners linked to a centralised database and has been held up by problems with the IT architecture underpinning the system.

The scheme was officially announced in a speech by FDA Commissioner Margaret Hamburg in February, in which she cited a number of cases in recent years including melamine contamination of pet food, diethylene glycol (DEG) in toothpaste and of course the contaminated heparin case which caused hundreds of deaths around the world in 2008. 

PREDICT would alleviate pressure on the agency's "modest" inspectorate by boosting other areas of oversight in the supply chain, she added.


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